QA Advisor - Global Business Services AstraZeneca India

About AstraZeneca India

Job Description

As a QA Advisor within the Global Business Services (GBS) at AstraZeneca, you will play a critical role in contributing to the long-term ambition of the organization to improve the lives of millions of patients by delivering new medicines. Your main focus will be on defining and delivering GBS opportunities within the Research & Development (R&D) areas of the business, supporting the establishment of Research & Development (R&D) Services to enhance customer focus and strengthen relationships with SET areas. Your contributions will be integral to driving AstraZeneca's vision of growth and change, ensuring timely and accurate quality and compliance from the Bangalore hub to support global pharmacovigilance efforts and ultimately enhance patient safety worldwide. In this role, you will be responsible for supporting the efficient processing and reporting of adverse event cases within regulatory timelines, implementing standard operating procedures (SOPs) for case intake and processing, and preparing quality-related documentation. You will collaborate with internal and external stakeholders to ensure compliance with global regulatory requirements, participate in internal assessments, external audits, and regulatory inspections, and drive best practices for audit and inspection management. Additionally, you will lead investigations into quality issues, deviations, and non-conformances, and provide support for Corrective and Preventive Actions. Your role will also involve supporting internal training programs related to audit/inspection readiness, compliance, and quality performance indicators, contributing to the development and optimization of global patient safety processes, systems, and tools, and staying updated on regional and global pharmacovigilance regulations. You will leverage your expertise in pharmacovigilance, regulatory affairs, and safety quality assurance to maintain high-quality standards in case processing and reporting, while working collaboratively in a team environment. If you have a BA or BS degree, experience in the pharmaceutical or biotechnology industry, and a strong background in pharmacovigilance, regulatory affairs, or safety quality assurance, then this role offers you a unique opportunity to make a significant impact in a dynamic and ambitious environment. Join us at AstraZeneca and be part of a diverse and inclusive team that leverages technology and bold thinking to develop life-changing medicines. Apply now and be a part of our innovative world where we drive simplicity, efficiency, and real impact.,